Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta
dc.contributor.author | Wranke, Anika | |
dc.contributor.author | Hardtke, Svenja | |
dc.contributor.author | Heidrich, Benjamin | |
dc.contributor.author | Dalekos, George | |
dc.contributor.author | Yalcin, Kendal | |
dc.contributor.author | Tabak, Fehmi | |
dc.contributor.author | Yurdaydin, Cihan | |
dc.date.accessioned | 2020-12-01T11:58:35Z | |
dc.date.available | 2020-12-01T11:58:35Z | |
dc.date.issued | 2020 | |
dc.department | Ege Üniversitesi | en_US |
dc.description.abstract | Hepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFN alpha-2a) is the only effective treatment but its long-term clinical impact is unclear. the aim of this study was to investigate the long-term outcome after 48 weeks of pegylated interferon alpha-2a therapy. We performed a retrospective follow-up study of the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-I trial). Patients had received 48 weeks of treatment with either PEG-IFN alpha-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFN alpha-2a alone (Group II) or adefovir dipivoxil alone (Group III). Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child-Pugh scores B or C or an increase in Model for End-stage Liver Disease (MELD) scores of five or more points in relation to baseline values. Patients were considered for further analysis when they were retreated with PEG-IFN alpha-2a. Follow-up data (at least 1 visit beyond post-treatment week 24) were available for 60 patients [Group I, (n = 19), Group II (n = 20), Group III (n = 21)]. Mean time of follow-up was 8.9 (1.6 - 13.4) years. 19 patients were retreated with IFN-based therapy: 42% (n = 8) in PEG-IFN alpha-2a arms and 58% (n = 11) in the adefovir only arm. Clinical complications on long-term follow-up occurred in 17 patients and were associated with nonresponse to therapy and baseline cirrhosis. the annual event-free survival rate in patients with cirrhosis vs noncirrhotic patients at year 5 and 10 was 70% vs 91% and 35% vs 76%. Long-term follow-up of a large randomized clinical trial suggests that off-treatment HDV RNA response to PEG-IFN alpha-2a treatment leads to improved clinical long-term outcome. | en_US |
dc.description.sponsorship | German Centre for Infection Research (DZIF), partner site Hannover-Braunschweig; German Liver Foundation; EASL registry grant | en_US |
dc.description.sponsorship | This study was funded by the German Centre for Infection Research (DZIF), partner site Hannover-Braunschweig with a grand to the HepNet Study-House, the German Liver Foundation and an EASL registry grant. | en_US |
dc.identifier.doi | 10.1111/jvh.13366 | en_US |
dc.identifier.endpage | 1368 | en_US |
dc.identifier.issn | 1352-0504 | |
dc.identifier.issn | 1365-2893 | |
dc.identifier.issue | 12 | en_US |
dc.identifier.pmid | 32707605 | en_US |
dc.identifier.scopus | 2-s2.0-85089259771 | en_US |
dc.identifier.scopusquality | Q2 | en_US |
dc.identifier.startpage | 1359 | en_US |
dc.identifier.uri | https://doi.org/10.1111/jvh.13366 | |
dc.identifier.uri | https://hdl.handle.net/11454/62058 | |
dc.identifier.volume | 27 | en_US |
dc.identifier.wos | WOS:000558543300001 | en_US |
dc.identifier.wosquality | Q2 | en_US |
dc.indekslendigikaynak | Web of Science | en_US |
dc.indekslendigikaynak | Scopus | en_US |
dc.indekslendigikaynak | PubMed | en_US |
dc.language.iso | en | en_US |
dc.publisher | Wiley | en_US |
dc.relation.ispartof | Journal of Viral Hepatitis | en_US |
dc.relation.publicationcategory | Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı | en_US |
dc.rights | info:eu-repo/semantics/openAccess | en_US |
dc.subject | chronic hepatitis | en_US |
dc.subject | clinical outcome | en_US |
dc.subject | delta virus | en_US |
dc.subject | endpoint | en_US |
dc.subject | Hepatitis D | en_US |
dc.title | Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta | en_US |
dc.type | Article | en_US |